Rumor: Is Apple’s iWatch Stuck in FDA Limbo?

With the expected launch date for Apple’s (NASDAQ:AAPL) fabled iWatch a little over three months away, the perpetual tech industry rumor mill appears to have moved into high gear. The most recent rumor comes courtesy of Chinese news siteLaoyaobaviaGforGames. According to “Apple insiders” cited by Laoyaoba, the technical specifications and design of the iWatch have already been finalized, but the production of the device is on hold while the company waits for approval from the Food and Drug Administration. This indicates that the iWatch is being certified as a diagnostic medical device, rather than a purely educational or informational product.

An FDA memo recently obtained byApple Toolbox provided an overview of the discussions that took place between Apple and FDA officials in a meeting last year. Much of the conversation described in the memo revolved around what would qualify a health-monitoring mobile device for regulation by the FDA, including a long discussion about a hypothetical mobile device that monitored blood glucose. Tellingly, Laoyaoba’ssources reported that the iWatch would include biometric sensors to monitor heart rate, blood pressure, and blood glucose. The sources also reported that Apple had developed its own proprietary sweat analysis sensor for the iWatch.

While getting FDA certification adds another hurdle that Apple must clear before it can release the iWatch, the decision to design the device as a medical diagnostic tool will likely give the iWatch a competitive edge over other wearable tech devices on the market that only offer health metrics without the weight of an FDA certification behind them. It also aligns with the company’s decision to develop its HealthKit data storage platform with the cooperation of the Mayo Clinic. As a certified medical device, the information collected by Apple’s iWatch will be qualified to be integrated with other health record information at participating health institutions.